A Randomized, Double-blind, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MET233 in Otherwise Healthy Adult Participants With Obesity or Overweight
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The goal of this clinical trial is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of once-weekly subcutaneous injections of MET233 in otherwise healthy adults with overweight or obesity. The trial will be conducted in three parts. Part A consists of single ascending dose (SAD) cohorts of MET233 or placebo. Part B consists of multiple ascending dose (MAD) cohorts, with participants treated with five once-weekly doses of MET233 or placebo. In Part C, participants will receive once-weekly doses of MET233 or placebo for 12 weeks, followed by a single higher, potential monthly dose.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:
• Adult (≥18 to ≤70 years) male and female participants with obesity or overweight (BMI 27.0 kg/m2 to 38.0 kg/m2, inclusive) but otherwise healthy.
Locations
United States
California
MET233 Research Site 001
RECRUITING
Cypress
Contact Information
Primary
Metsera Recruiting
clinicaltrials@metsera.com
888-746-7403
Time Frame
Start Date:2024-11-20
Estimated Completion Date:2026-01-03
Participants
Target number of participants:120
Treatments
Experimental: (Part A) MET233
Participants will receive a single dose of MET233 at up to 5 dose levels
Placebo_comparator: (Part A) Placebo
Participants will receive a single dose of placebo
Experimental: (Part B) MET233
Participants will receive five weekly doses of MET233 at up to 4 dose levels
Placebo_comparator: (Part B) Placebo
Participants will receive five weekly doses of placebo
Experimental: (Part C) MET233
Participants will receive twelve weekly doses of MET233 at up to 4 dose levels, followed by a 13th potential monthly dose
Placebo_comparator: (Part C) Placebo
Participants will receive twelve weekly doses of placebo, followed by a 13th potential monthly dose